Early phase clinical trial to test the feasibility of an ACT-based physical activity promotion program for adults with depressive symptoms

早期临床试验旨在测试基于 ACT 的体力活动促进计划针对患有抑郁症状的成年人的可行性

• 批准号: 10462685
• 负责人: David M Williams
• 金额: $ 35.4万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462685
• 关键词: Accelerometer; Address; Adherence; Adoption; Adult; Aftercare; Age; Attention; Awareness; Behavioral; Benchmarking; Chronic; Chronic Disease; Client satisfaction; Clinical Practice Guideline; Clinical Trials; Data; Data Collection; Dementia; Depressed mood; Development; Distress; Economic Burden; Education; Educational Intervention; Enrollment; Fostering; Frequencies; Future; Goals; Health education; Individual; Intervention; Maintenance; Manuals; Mediator of activation protein; Mental Depression; Monitor; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Participant; Persons; Phase; Philanthropic Fund; Physical activity; Population; Procedures; Productivity; Protocols documentation; Psychologist; Questionnaires; Randomized; Research; Risk; Running; Site; Symptoms; Time; Training; Treatment Protocols; Work; base; behavior change; chronic back pain; clinically significant; community based treatment; depressive symptoms; disability; distress tolerance; early phase clinical trial; ethnic minority; exercise intervention; experience; feasibility testing; feasibility trial; follow-up; mindfulness; motivational enhancement therapy; negative affect; pilot test; primary outcome; programs; racial and ethnic; recruit; response; treatment group; treatment trial; trial comparing

ABSTRACT Up to 25% of U.S. adults have clinically significant depressive symptoms5,6 and people who experience these symptoms are at increased risk of all-cause mortality7 and chronic disease8-23 Engaging in regular physical activity (PA) can help alleviate depressive symptoms27-31 and reduce risk of chronic diseases, such as CVD32-36 and type 2 diabetes,37-41 that are associated with depression. Despite the benefits of PA for those with depressive symptoms, depressive symptoms consistently predict PA nonadherence.42-45 Factors such as decreased distress tolerance46-52 and low motivation53-60 make adherence to regular PA particularly difficult for adults with depressive symptoms. Thus, an important problem that needs to be addressed is how to help adults with depressive symptoms overcome barriers to regular PA. Acceptance and Commitment Therapy (ACT)61,62 is a mindfulness-informed intervention that is efficacious for fostering behavior change in various healthy populations and for treating depression. ACT enhances motivation for functional activities in depressed individuals by helping them to clarify personal values consistent with behavioral goals, and foster present- moment, nonjudgmental awareness (i.e., mindfulness) and acceptance of internal experiences to increase distress tolerance. These foci of ACT may be applied to address the intolerance of negative affective response to PA and low motivation for PA that serve as barriers to regular PA among adults with depressive symptoms. The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based ACTivity to PA+Education among 60 low-active adults (ages 18-65) with elevated depressive symptoms at two Greater Providence YMCA branches. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities. Aim 1: Develop and demonstrate training and intervention fidelity procedures for bachelor’s level interventionists to direct the ACTivity and PA+Education interventions. Aim 2: Demonstrate feasibility of recruitment, randomization, retention, and data collection procedures to conduct an individually randomized group treatment trial (IRGT). Aim 3: Demonstrate credibility (i.e., how convincing and logical a treatment seems) and acceptability of the ACTivity and PA+Education programs. Impact: The proposed research is a necessary step to prepare for a future multi-site RCT that has the potential to change clinical practice guidelines if shown to be effective. Specifically, if shown to be effective, ACTivity will provide a community- based treatment that can be delivered at local YMCAs by bachelor’s level staff to increase MVPA among depressed adults and thereby decrease their risk for chronic disease.

抽象的 多达25％的美国成年人患有临床上显着的抑郁症状5,6和经历这些的人 症状有增加全因死亡率的风险7和慢性病8-23从事常规身体 活动（PA）可以帮助减轻抑郁症状27-31并降低慢性疾病的风险，例如CVD32-36 和2型糖尿病，37-41与抑郁有关。尽管PA受益于那些 抑郁症状，抑郁症状始终预测PA不遵守。42-45个因素，例如 降低的遇险公差146-52和低动机53-60使对常规PA的遵守特别困难 患有抑郁症状的成年人。那是一个需要解决的重要问题是如何提供帮助 抑郁症状的成年人克服了常规PA的障碍。接受和承诺疗法 （ACT）61,62是一种有意义的干预措施，可有效促进各种行为变化 健康的人群和治疗抑郁症。 ACT增强了沮丧的功能活动的动力 通过帮助他们澄清与行为目标一致的个人价值观，并促进当下的个人价值观 - 时刻，非判断性意识（即正念）和接受内部经验以增加 遇险宽容。这些ACT的焦点可以应用于解决负面情感反应的肠道 在PA和PA的动力低下，在患有抑郁症状的成年人中是常规PA的障碍。 拟议项目的目的是进行可行性临床试验，将基于组的活动与 PA+在60名低活动成年人（18-65岁）中的教育，抑郁症状升高，两个更大 普罗维登斯基督教青年会分支机构。参与者将被随机分配到治疗状态，然后持续6个月， 包括为期8周的治疗，并获得6个月的基督教青年会会员资格，以平等地进入PA设施。 目标1：为单身汉制定并展示培训和干预保真程序 干预主义者指导活动和PA+教育干预措施。目标2：证明可行性 招募，随机化，保留和数据收集程序，以进行单独随机 小组治疗试验（IRGT）。目标3：证明信誉（即，如何令人信服和逻辑 影响：拟议的研究是 为将来有可能改变临床实践的多站点RCT做准备的必要步骤 指南如果证明是有效的。特别是，如果证明是有效的，活动将为社区提供 - 学士学位员工可以在当地的YMCAS进行基于基于的治疗方法，以增加MVPA 沮丧的成年人，从而降低了慢性疾病的风险。

项目成果

Testing the Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention to Increase Physical Activity among Individuals with Depression: A Protocol Paper.

• DOI: 10.1016/j.mhpa.2022.100475
• 发表时间: 2022-10
• 期刊: Mental health and physical activity
• 影响因子: 4.7
• 作者: Lisa R. LaRowe;Lauren Connell Bohlen;B. Gaudiano;Ana M. Abrantes;M. Butryn;S. Dunsiger;Elizabeth Griffin;E. Loucks;L. Uebelacker;Dave Williams